ATryn

Product NDC
42976-121
11-digit product format
429760121
Labeler code
42976
Product ID
42976-121_634fb454-4f7f-4b30-9f89-fd3a122cf074
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Antithrombin Recombinant
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
rEVO Biologics, Inc.
Application
BLA125284
Marketing category
BLA
Marketing start
2009-05-06
Marketing end
0000-00-00
Substance
ANTITHROMBIN ALFA
Active strength
1750 [iU]/mL
Pharmacologic classes
Decreased Coagulation Factor Activity [PE],Thrombin Inhibitors [MoA],Factor Xa Inhibitors [MoA],Recombinant Antithrombin [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42976-121-022020-01-31C16284748780-19d75b9d0-3b44-f424-e053-dadaa90a57ceed3eaf69-1cbd-4b01-a6fa-1fe02c90c3e1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42976-121-02EA - Each42976-12185963efe-a933-4884-973d-bbdb1971ce7712016-02-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42976-121-02429760121021 VIAL in 1 CARTON (42976-121-02) > 3 mL in 1 VIAL1 vial2009-05-060000-00-00NoNoCurrent